Abylqis: Withdrawal of the marketing authorisation application
arachis hypogaea extract
Table of contents
Overview
DBV Technologies withdrew its application for a marketing authorisation of Abylqis for the treatment of peanut allergies.
The company withdrew the application on 17 December 2021.
Key facts
Name |
Abylqis |
Product number |
EMEA/H/C/004810 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
17/12/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Abylqis (PDF/7.31 MB)
Adopted
First published: 23/11/2022
EMA/772201/2021 -
List item
Withdrawal letter: Abylqis (PDF/20.25 KB)
First published: 28/01/2022 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Abylqis (Arachis hypogaea extract) (PDF/113.77 KB)
First published: 28/01/2022
Last updated: 23/11/2022
EMA/45097/2022 -
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').